Feasibility of Integrated Care of Depression in Primary C... | NCT06036160

Studies
Feasibility of Integrated Care of Depression in Primary Care Pathways

NCT06036160

Sponsor

Association De La Msp Pasteur

Status

Not yet recruiting

Last Update Posted

Aug 6, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Depressive Disorder

Interventions

Integrated care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Sep 5, 2023

First Submission Date that Met QC Criteria

Sep 12, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2024

Last Update Posted Date

Aug 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Integrated care	Experimental		Other: Integrated care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Integrated care	Other	Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation	Integrated care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients completing the study per-protocol		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-65 years
Good understanding of french language
Major depressive disorder based on DSM-V criteria
MADRS > 19
FAilure of two antidepressants during 6wks at standard minimal dose

Exclusion Criteria:

Pregnancy or lactating
People under tutelage
bipolar disorder
no health insurance
neurological disorders
contra-indication to physical activity
high suicidal risk
first degree history of bipolar disorder, schizophrenia, autism spectrum disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019033	Delivery of Health Care, Integrated

Ancestor Terms

ID	Term
D003695	Delivery of Health Care
D010346	Patient Care Management
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided